FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of Asthma
London UK 9 September 2020 -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium /... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 10, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain
ATHENS, Ga., Sept. 8, 2020 /PRNewswire/ -- Athena Bioscience, LLC, a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Qdolo™ (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 9, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Detectnet (copper Cu 64 dotatate injection) Positron Emission Tomography (PET) Agent
Houston, TX and St. Louis, MO, Sept. 08, 2020 (GLOBE NEWSWIRE) -- RadioMedix Inc. and its commercial partner Curium announced today that Detectnet (copper Cu 64 dotatate injection) was approved by the U.S. Food and Drug Administration (FDA). ... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 8, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
South San Francisco, CA -- September 4, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 4, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Additional Doses of Trulicity (dulaglutide) for the Treatment of Type 2 Diabetes
INDIANAPOLIS, Sept. 3, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today approved two additional doses of Eli Lilly and Company's (NYSE: LLY) Trulicity® (dulaglutide). The approval expands the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 3, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
PRINCETON, N.J.--(BUSINESS WIRE) September 1, 2020 --Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 2, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xaracoll (bupivacaine hydrochloride) Implant for Acute Postsurgical Pain Relief Following Open Inguinal Hernia Repair
ATHLONE, Ireland, Aug. 31, 2020 /PRNewswire/— Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today that the US Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 31, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Sogroya (somapacitan-beco) a Once-Weekly Treatment for Adult Growth Hormone Deficiency
Plainsboro, NJ, Aug 28, 2020 - Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for Sogroya (somapacitan-beco) injection 10 mg/ 1.5 mL (6.7 mg/mL) for the replacement of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 29, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne
Lainate, Italy– August 27, 2020– Cassiopea SpA (SIX: SKIN), today announced that the United States Food and Drug Administration (FDA) approved Winlevi (clascoterone cream 1%) for the treatment of acne in patients 12 years and older.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 27, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Cystadrops (cysteamine) Ophthalmic Solution for the Ocular Manifestations of Cystinosis
LEBANON, N.J., Aug. 25, 2020 /PRNewswire/ -- Recordati Rare Diseases Inc., today announced the U.S. Food and Drug Administration (FDA) has approved Cystadrops (cysteamine ophthalmic solution) 0.37%. Cystadrops is a new, viscous eye drop solution... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 26, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kesimpta (ofatumumab) Targeted B-cell Therapy for Patients with Relapsing Multiple Sclerosis
Basel, August 20, 2020 — Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 20, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves New Kyprolis (carfilzomib) Combination Regimen with Darzalex (daratumumab) and Dexamethasone in Both Once- And Twice-Weekly Dosing Regimens
THOUSAND OAKS, Calif., Aug. 20, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved the expansion of the Kyprolis (carfilzomib) U.S. prescribing information to include its use in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 20, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder
South San Francisco, CA -- August 14, 2020 -- Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) as the first and only subcutaneous treatment for adults... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 14, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Viltepso (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in Patients Amenable to Exon 53 Skipping Therapy
PARAMUS, N.J., Aug. 12, 2020 /PRNewswire/ -- NS Pharma, Inc. announced today that the U.S. Food& Drug Administration (FDA) has approved Viltepso (viltolarsen) injection for patients with Duchenne muscular dystrophy (DMD) who are amenable to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 12, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Olinvyk (oliceridine) Injection for the Management of Severe Acute Pain
CHESTERBROOK, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 10, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older
South San Francisco, CA -- August 7, 2020 -- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) in adults and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 8, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lampit (nifurtimox) for the Treatment of Chagas Disease in Children
WHIPPANY, N.J.--(BUSINESS WIRE) August 7, 2020 -- Bayer announced today that the United States Food and Drug Administration (FDA) has approved Lampit (nifurtimox) for use in pediatric patients (from birth to less than 18 years of age and weighing at... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 7, 2020 Category: Drugs & Pharmacology Source Type: news

ViiV Healthcare Announces FDA Approval of an Expanded Indication for Dovato (dolutegravir/lamivudine), a Complete Two-Drug Regimen for Virologically Suppressed Adults with HIV-1
London, 6 August 2020 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Dovato... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 6, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Blenrep (belantamab mafodotin-blmf) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
London UK 05 August 2020 -- GlaxoSmithKline announced the US Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 5, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Epidiolex (cannabidiol) Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex
CARLSBAD, Calif., Aug. 03, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with its U.S. subsidiary Greenwich... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 3, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Spravato (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior
TITUSVILLE, N.J.– (August 3, 2020)– The Janssen Pharmaceutical Companies of Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Spravato... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 3, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Monjuvi (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
PLANEGG/MUNICH, Germany - August 1, 2020 and WILMINGTON, Del. - July 31, 2020 MorphoSys AG NASDAQ:MOR) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi (tafasitamab-cxix) in combination... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 1, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma
South San Francisco, CA -- July 30, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 30, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Stelara (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
HORSHAM, Pa., July 30, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Stelara (ustekinumab) as a treatment... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 30, 2020 Category: Drugs & Pharmacology Source Type: news

Ortikos (budesonide), the First and Only Once-Daily Dose for Treatment of Mild to Moderate Crohn ’s Disease, Now Available in the U.S.
Parsippany, NJ– July 29, 2020– Ferring Pharmaceuticals Inc. today announced the launch of Ortikos (budesonide) in the United States, which is approved as the only once-daily treatment of mild to moderate active Crohn’s disease... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 30, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xeglyze (abametapir) Lotion for the Treatment of Head Lice
HYDERABAD, India& PRINCETON, N.J.--(BUSINESS WIRE) July 27, 2020 --Dr. Reddy’s Laboratories Ltd. today announced approval of Xeglyze (abametapir) lotion, 0.74%, a 505(b)(1) NDA by the U.S. Food and Drug Administration. The approval... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 28, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tecartus (brexucabtagene autoleucel) as the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma
SANTA MONICA, Calif.--(BUSINESS WIRE)--Jul. 24, 2020-- Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus™ (brexucabtagene... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 25, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the Maintenance Treatment of COPD
24 July 2020 -- AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The approval by the US... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 25, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy
DUBLIN, July 22, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 22, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Wynzora Cream (calcipotriene and betamethasone dipropionate) for Adults with Plaque Psoriasis
COPENHAGEN, Denmark, July 22, 2020 / B3C newswire / -- MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 22, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Wynzora Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%) for Adults with Plaque Psoriasis
COPENHAGEN, Denmark, July 22, 2020 / B3C newswire / -- MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 22, 2020 Category: Drugs & Pharmacology Source Type: news

Averitas Pharma Announces FDA Approval of Qutenza for the Treatment of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy of the Feet
AACHEN, Germany and MORRISTOWN, N.J., July 21, 2020 /PRNewswire/ -- Grünenthal announced today that its U.S. subsidiary Averitas Pharma, Inc. received U.S. Food and Drug Administration (FDA) approval for Qutenza (capsaicin) 8% patch for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 22, 2020 Category: Drugs & Pharmacology Source Type: news

Tremfya (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis
HORSHAM, PA, July 14, 2020– The Janssen Pharmaceutical Companies of Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 14, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Upneeq (oxymetazoline hydrochloride ophthalmic solution) for Acquired Blepharoptosis (Droopy Eyelid) in Adults
BRIDGEWATER, N.J, July 09, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the“Company”), a fully integrated biopharmaceutical company, announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 9, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Hulio (adalimumab-fkjp), a Biosimilar to Humira
HERTFORDSHIRE, England and PITTSBURGH and TOKYO, July 9, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 9, 2020 Category: Drugs & Pharmacology Source Type: news

Ipsen Announces Updated Indication for Dysport (abobotulinumtoxinA) for the Treatment of Spasticity in Children
CAMBRIDGE, Mass.--(BUSINESS WIRE) July 09, 2020 --Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), announced today that the United States Food and Drug Administration (FDA) has approved the expanded use of Dysport... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 9, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Botox (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity
NORTH CHICAGO, Ill., July 9, 2020 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) that supports expanded use of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 9, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Inqovi (decitabine and cedazuridine) for Myelodysplastic Syndromes (MDS) including Chronic Myelomonocytic Leukemia (CMML)
Pleasanton, CA, Princeton, NJ, and Tokyo, Japan, July 7, 2020. Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 8, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Qwo (collagenase clostridium histolyticum-aaes) as the First Injectable Treatment for Cellulite
DUBLIN, July 6, 2020 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced that it received U.S. Food and Drug Administration (FDA) approval of Qwo (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 6, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Byfavo (remimazolam injection) for the Induction and Maintenance of Procedural Sedation
Dublin, Ireland– 2 July 2020: Cosmo Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has approved Byfavo (remimazolam injection) for the induction and maintenance of procedural sedation in adults undergoing... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 2, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rukobia (fostemsavir) for HIV in Adults with Few Treatment Options Available
July 2, 2020 -- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 2, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Dojolvi (triheptanoin) for the Treatment of Long-Chain Fatty Acid Oxidation Disorders
NOVATO, Calif., June 30, 2020 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, today announced... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 30, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Bavencio as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma
Rockland, MA and New York, US, JUNE 30, 2020– EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 30, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for HER2-Positive Breast Cancer
South San Francisco, CA -- June 29, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Phesgo, a fixed-dose combination (FDC) of Perjeta®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 29, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Merck ’s Keytruda (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
KENILWORTH, N.J.--(BUSINESS WIRE) June 29, 2020 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 29, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Mycapssa (octreotide) Oral Somatostatin Analog for Acromegaly
NEEDHAM, Mass., June 26, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), a commercial stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) approved Mycapssa (octreotide) capsules for long-term... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 27, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fintepla (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome
EMERYVILLE, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Fintepla... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 26, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Merck ’s Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that is Not Curable by Surgery or Radiation
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 24, 2020 Category: Drugs & Pharmacology Source Type: news

Karyopharm Announces FDA Approval of Xpovio (selinexor) for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
NEWTON, Mass., June 22, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved oral Xpovio® (selinexor), the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 22, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves New Dupixent (dupilumab) Pre-Filled Pen Designed to Support More Convenient Self-Administration
CAMBRIDGE, Mass. and TARRYTOWN, N.Y., June 19, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a 300 mg single-dose pre-filled pen for Dupixent® (dupilumab). The pre-filled pen is... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 20, 2020 Category: Drugs & Pharmacology Source Type: news